DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-80A/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-80/DC-80/DC-80/DC-80/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediative cardiac, peripheral vessel and urology exams.
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color M-mode, Power/Dirpower mode, TDI mode, THI, iScape, Biopsy Guidance, 3D/4D mode, Elastography, Contrast imaging or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.
The provided text describes the regulatory clearance for the DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System. However, it does not contain specific acceptance criteria, detailed study results, or performance metrics for an AI model.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications, intended uses, and compliance with various safety and performance standards for an ultrasound system, not an AI component. It states "Clinical Tests: Not Applicable." indicating that a clinical study to prove the device meets acceptance criteria via performance metrics for an AI system was not performed or deemed necessary for this 510(k) submission.
Therefore, I cannot populate the requested tables and information based on the provided text, as the information is not present. The document is about the FDA clearance of an ultrasound system, not an AI software/device that would typically have specific performance acceptance criteria demonstrated through a clinical study with detailed results, ground truth, and expert evaluation.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.